Georgetown University Center of Excellence in Regulatory Science and Innovation Project Summary/Abstract Regulatory Science is an interdisciplinary field that can transform biomedical research and education. As academic medical centers embrace team-science approaches, regulatory science represents a platform by which researchers can collaborate to address scientific challenges and participate in the development of safe and effective medical products. Regulatory science and medicine comprise an emerging, specialized, and interdisciplinary field of applied biomedical research and education with applications to science, medicine, public health, and policy. The translation and practical application of scientific evidence influences the development and lifecycle of new pharmacological therapies, biologics, devices, and diagnostics. The field holds great promise for training, scholarship, and innovation to inform decision makers and enhance the development and utility of medical products. Georgetown University has a vested interest in regulatory science through its Program for Regulatory Science & Medicine (PRSM). Advantaged by resources in scientific discovery and clinical research, and with geographical proximity to regulators and policy makers, Georgetown University offers specialized, interdisciplinary opportunities in a collaborative research and training environment for regulatory scientists and others invested in the innovation of medical products. Georgetown University Medical Center (GUMC) provides a unique milieu to promote regulatory science. With established ties to the U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), industry trade organizations, and policy makers, GUMC attracts top-tier students from around the country and worldwide to study in its graduate education programs. In addition, GUMC provides a rich training opportunity for post-doctoral fellows and long- term career opportunities for faculty and staff. We propose to strategically develop our established Collaborating Center of Excellence in Regulatory Science and Innovation (CERSI) into a world-class leader in regulatory science, engaging participation from students, faculty, investigators, and innovators from across the university, other academic institutions, industry, and government. The overall aim of the FDA-Georgetown CERSI is to create and secure new and existing research, education, training, and scientific exchange opportunities in regulatory science. Since our initial award in 2011, we have established and refined the core features of our program, including collaborative research projects among Georgetown and FDA personnel, and educational and training offerings. In addition, we have used the CERSI as a means to foster and create relationships and partnerships within and beyond the university, including the Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS; an NIH-supported CTSA), Georgetown University Law Center, Georgetown University Innovation Center for Biomedical Informatics (ICBI), MedStar Health, Pharmaceutical Research and Manufacturers of America (PhRMA), and others. Our foundational CERSI award enabled these productive partnerships and programs.